Gonal-f® RFF 75 IU Vial

Gonal-f® RFF 75 IU Vial

(follitropin alfa for injection)

To help you prepare and use the Gonal‑f® RFF 75 IU Vial, you should read the patient information leaflet contained in the box and ask your doctor, nurse, or pharmacist to explain anything you do not understand. You should keep the leaflet as you may want to read it again.

Read the patient information each time you get a refill, because there may be new information. The leaflet does not take the place of talking with your healthcare provider about your condition or treatment.

• What is the Gonal-f RFF 75 IU Vial?
• What are the uses of the Gonal‑f® RFF 75 IU Vial?
• Medical conditions I should tell my doctor about
• What are the possible side effects of the Gonal-f^® RFF 75 IU Vial?
• How should I use Gonal-f^® RFF 75 IU Vial?
• What should I do if I forget to take the Gonal-f RFF 75 IU Vial?
• Can I take the Gonal-f RFF 75 IU Vial with other medicine?
• Storing my Vial of Gonal‑f® RFF 75 IU Vial
• Gonal-f RFF 75 IU Vial use instructions (Video)
• Download Full Prescribing Information for Gonal-f® (follitropin alfa for injection) RFF 75 IU Vial
• Where can more information about the Gonal-f RFF 75 IU Vial be obtained?

What is Gonal-f RFF 75 IU Vial?

Gonal‑f® RFF 75 IU Vial is an injectable hormone contained in a stoppered glass vial. The hormone in the vial is in the form of a white powder. The carton containing the vial of drug also contains a syringe labeled ‘Bacteriostatic Water for Injection, USP’. This water must be mixed with the white powder in the vial to form a clear liquid solution for injection. Injection syringes for use with Gonal‑f® RFF 75 IU Vial are also included in the carton. These injection syringes can only be used to administer Gonal‑f® RFF 75 IU Vial. Gonal‑f® RFF 75 IU Vial is only available with a prescription.

Gonal‑f® contains follitropin alfa, which is similar to the human hormone ‘follicle stimulating hormone’; the abbreviation is ‘FSH’. FSH belongs to the group of hormones associated with human reproduction. In women, FSH causes the ovaries to produce eggs. In men, FSH causes sperm production.

The hormone in Gonal‑f® is manufactured to meet standards for quality and purity. It cannot be taken by mouth since the acids in your stomach would destroy the hormone before it was absorbed into the body.

Gonal‑f® is given as an injection usually every day in women and three times per week in men. It is prescribed to patients needing hormone replacement or supplementation to produce either eggs or sperm.

Your doctor or nurse will tell you the number of units (IU FSH) of Gonal‑f® to use each day and the number of days to use the same vial. It is common for a small amount of drug to be leftover in each vial that cannot be retrieved with a syringe. This is normal. Any drug remaining in the vial after your treatment is complete should be discarded.

Your doctor, nurse, or pharmacist will show you how to inject the prescribed dose. Usual injection sites include the skin on the stomach, upper leg, or upper arm.

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What are the uses of Gonal‑f® RFF 75 IU Vial?

Doctors specializing in infertility or reproductive health prescribe Gonal‑f® RFF 75 IU Vial to those patients trying to have a child but for a variety of reasons need medical assistance. After a thorough medical exam to determine your specific medical condition, your doctor may prescribe Gonal‑f® RFF 75 IU Vial because you require hormone replacement or supplementation as part of your treatment program.

Gonal‑f® RFF 75 IU Vial can be used in women seeking pregnancy or in men with a rare condition that affects sperm production. Gonal‑f® RFF 75 IU Vial may be one of several drugs prescribed to a patient as part of a treatment program.

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Medical conditions you should tell your doctor about.

If you have any of the following conditions, make sure to tell your doctor before starting or continuing use of Gonal‑f®:

• Abnormal bleeding from the uterus or vagina in women
• Swollen, enlarged or painful ovaries in women
• Cancer of the sex organs (uterus, ovaries, testes)
• Permanent damage to the male sex organs (testes)
• Uncontrolled thyroid or adrenal problems
• Cancer of the brain

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What are the possible side effects of Gonal-f^® RFF 75 IU Vial?

Your doctor or staff member should review with you the risks and benefits of using Gonal‑f® RFF 75 IU Vial. As with any medication, report any and all side effects, symptoms, or physical changes to your doctor.

The most common side effects are headache, ovarian cysts, upset stomach, and sinus infections in women and skin pimples, breast pain and growth, and tiredness in men. Needle injections may cause some discomfort.

Use of fertility drugs can be associated with fertilization of more than 1 egg. This can lead to complications for the mother and the birth of 2 or more babies. Pregnancy loss (miscarriage) is higher in women receiving fertility drugs than in women not taking fertility drugs.

Gonal‑f® is a potent drug which should be used at the lowest dose expected to achieve the desired results. When used in women, your doctor should monitor your response often to avoid overdose which can lead to serious side effects including blood clots.

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How should I use Gonal-f RFF 75 IU Vial?

You may self-inject Gonal-f RFF 75 IU Vial after special instruction from your doctor.

Gonal-f RFF 75 IU Vial is for injection under the skin of the lower abdominal area, preferably around, but staying at least one inch away from the belly button.

Before you inject Gonal-f RFF 75 IU Vial yourself, please carefully read the instructions included in the packet with the needles and pre-filled syringe.

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What should you do if you forget to take Gonal-f RFF 75 IU Vial?

Do NOT take a double dose of Gonal‑f®. Contact your doctor if you forget to take a dose of Gonal‑f®.

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Can you take Gonal-f RFF 75 IU Vial with other medicine?

Inform your doctor and pharmacist if you are taking or have taken any other medicines, even those not requiring a prescription.

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Storing Your Vial of Gonal‑f® RFF 75 IU Vial Between Uses

After each use, the vial containing the Gonal‑f® RFF 75 IU Vial liquid must be stored away from light and may be stored refrigerated or at room temperature between 36°- 77° F (2°- 25° C) for up to 28 days. Otherwise, the drug’s potency can be reduced. Do not store the drug in the syringe.

• If you are traveling, keep the vial stored away from light and extreme temperatures. Do not freeze.
• Allow the liquid solution to adjust to room temperature prior to administering your injection.
• Check that the Gonal‑f® liquid solution is clear. Do not use if it contains any particles. Report this to your doctor, nurse or pharmacist immediately.

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Gonal-f RFF 75 IU Vial use instructions

Watch this brief video that demonstrates how to administer Gonal-f® RFF 75 IU Vial.

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Download Full Prescribing Information for Gonal-f® (follitropin alfa for injection) RFF 75 IU Vial

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Where can I find more information about Gonal-f RFF 75 IU Vial?

This information on this website is a summary of the important patient information about Gonal‑f® RFF 75 IU Vial. If you have any questions or problems, talk to your doctor or other health care provider.

Gonal‑f® RFF 75 IU Vial is manufactured and distributed by EMD Serono, Inc. You can contact EMD Serono at 1-866-538-7879.